Testing a gut bacteria treatment combined with immunotherapy for advanced lung cancer

Plain-English translation of NCT06448572 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing whether —a medication containing a naturally occurring beneficial bacteria found in healthy gut microbiota—works better when combined with nivolumab (an immunotherapy drug you may have already received) for treating advanced non-small cell lung cancer. You would receive this combination if your cancer has progressed despite previous immunotherapy and chemotherapy treatments. The study aims to see if this new pairing can help patients whose cancer has become resistant to standard therapies.

Patients with advanced lung cancer often run out of effective treatment options after their cancer stops responding to immunotherapy and chemotherapy. This medication is being studied because researchers believe that adding a beneficial gut bacteria might help boost the immune system's ability to fight cancer when combined with immunotherapy.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with advanced non-small cell lung cancer that cannot be treated with surgery or radiation
you have already received both an immunotherapy drug (anti-PD-L1 or anti-PD-1) and platinum-based chemotherapy, and your cancer got worse within 6 months of starting immunotherapy
you have tried all standard treatments available to you
your blood work shows adequate kidney, liver, and blood cell function
you are in generally good health with minimal physical limitations (performance status 0–1)

You likely don't qualify if…

you have small cell lung cancer or mixed lung cancer types
you have brain metastases (cancer spread to the brain) that are causing symptoms or require high-dose steroids
you have a weakened immune system or are taking high-dose steroids (more than 10 mg prednisone daily)
you have uncontrolled heart disease, recent stroke, or serious cardiac problems
you have had severe immune-related side effects (grade 3 or higher) from previous immunotherapy or a history of severe lung inflammation that required steroids

What participation looks like

You would receive and nivolumab, likely as infusions or injections at the hospital. This is a small pilot study with only about 21 participants total at one hospital location in Lille, France. You would attend regular clinic visits for treatment administration, blood tests, and scans to monitor how your cancer is responding, though the exact schedule isn't detailed in this summary. The study is designed to evaluate both whether this combination is safe and whether it shows promise in helping your cancer.

AI-generated summary from trial data · Jun 30, 2026 · Not medical advice

Trial locations(1 site)

France

CHU Lille, Lille